Ethics code should outlaw placebo controlled trials when an accepted treatment exists

The World Medical Association is currently considering revising the Declaration of Helsinki, which governs human research. On p 442 Rothman and Michels say that the declaration's protection of individuals is in danger of being weakened by organisations such as the US Food and Drug Administration and argue in particular that the declaration should outlaw placebo controlled trials where there is already an existing treatment. They suggest that this should be a global rule and apply not just in the West. Baum argues against the "absolutism" of this position. He uses the examples of cyclical mastalgia to argue that placebo contolled trials may sometimes be appropriate and of breast cancer screening in India to argue that ethical standards have to be interpreted in context.

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For and against: Declaration of Helsinki should be strengthened • FOR • AGAINST • Rothman and Michels' riposte

Kenneth J Rothman, Karin B Michels, and Michael Baum
BMJ 2000 321: 442-445. [Extract] [Full Text] [PDF]